The Safety and Efficacy of Alveolar Bone Defect Repair Induced by Gelatin Sponge-loaded Apoptotic Vesicle Complex

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-20

Study Completion Date

2024-07-30

Brief Summary

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Distal bone loss of the second molar due to extraction of the third molar is one of the most common pathological conditions that results in tooth loss of second molar. However, regeneration of functional alveolar bone has proved difficult. Therefore, the investigators conduct a two-arm study to evaluate the efficacy and safety of alveolar bone regeneration induced by gelatin sponge-loaded apoptotic vesicle complex in patients with mandibular third molar extraction.

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Detailed Description

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This study is a single-center, prospective, two-arm study to evaluate the efficacy and safety of alveolar bone regeneration induced by gelatin sponge-loaded apoptotic vesicle complex in patients with mandibular third molar extraction. This study plans to include 30 subjects from the Department of Stomatology of the Fifth Affiliated Hospital of Guangzhou Medical University. One socket for each participant in this study will receive gelatin sponge-loaded apoptotic vesicle complex after third molar extraction and socket debridement. The other side of socket for each participant in this study will receive commercial gelatin sponge after the same surgery. All participants will undergo screening and baseline visits. After surgery, the participants will be followed up for 1 year.

Conditions

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Third Molar Extraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Gelatin sponge-loaded apoptotic vesicle complex

4 \* 10\^10 apoptotic vesicles derived from umbilical cord mesenchymal stem cells were loaded in a gelatin sponge（Kuaikang®）. A piece of gelatin sponge-loaded apoptotic vesicle complex was placed in an extraction socket after tooth extraction.

Group Type EXPERIMENTAL

Gelatin sponge-loaded apoptotic vesicle complex（Kuaikang®)

Intervention Type DRUG

The experimental group

Gelatin sponge only

A piece of gelatin sponge（Kuaikang®）was placed in an extraction socket after tooth extraction.

Group Type ACTIVE_COMPARATOR

Gelatin sponge only （Kuaikang®)

Intervention Type DRUG

The positive control group

Interventions

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Gelatin sponge-loaded apoptotic vesicle complex（Kuaikang®)

The experimental group

Intervention Type DRUG

Gelatin sponge only （Kuaikang®)

The positive control group

Intervention Type DRUG

Other Intervention Names

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Gelatin sponge （Kuaikang®）. Apoptotic vesicles are derived from umbilical cord mesenchymal stem cells Gelatin sponge （Kuaikang®）

Eligibility Criteria

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Inclusion Criteria

1. Patients aged 18-45 (including the boundary value)
2. Patients who need to extract the bilateral mandible third molars
3. Patients who voluntarily sign the informed consent form

Exclusion Criteria

1. The adjacent second molars in the patient's oral cavity are affected by pulp injury or insufficient endodontic treatment, or show tooth fracture, or have a degree of motion of 3 degrees
2. The adjacent second molars have metal crowns or large amalgam restorations
3. There is an uncontrollable pathological process in the patient's oral cavity
4. Malnutrition (serum albumin concentration \<2 g/dl)
5. Other systemic, infectious diseases and hereditary diseases, or patients in the acute inflammatory phase and acute exacerbation phase of chronic diseases
6. Patients who are pregnant, lactating, or planning to become pregnant

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes